MAUDE Adverse Event Report: FEMCARE LTD FILSHIE CLIPS; LAPAROSCOPIC, CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Pain (1994); Rash (2033); Abnormal Vaginal Discharge (2123); Hematuria (2558)

Event Date 03/15/2019

Event Type  Injury  

Event Description

I was supposed to have a tubal ligation.During my c-section the doctor did the tubal ligation using filshie clamps.My body reacted to them and i have had a rash all over my body every day since.I have pain in my pelvic area along with discharge and blood in my urine.I have also had migraines.I had gone to my primary doctor multiple times, done bloodwork for allergies.I went back to my gynecologist and i'm supposed to have surgery to have these clamps removed next month.Fda safety report id # (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC, CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): FEMCARE LTD
• MDR Report Key: 8759827
• MDR Text Key: 150159004
• Report Number: MW5087840
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 29 YR
• Patient Weight: 89